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Last Updated: March 28, 2024

Acyclovir - Generic Drug Details


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What are the generic drug sources for acyclovir and what is the scope of freedom to operate?

Acyclovir is the generic ingredient in seven branded drugs marketed by Actavis Elizabeth, Apotex, Aurobindo Pharma Usa, Cadila, Cadila Pharms Ltd, Carlsbad Technology, Chartwell Molecules, Heritage Pharms, Indoco, Ivax Sub Teva Pharms, Lek Pharm, Mylan, Ranbaxy, Roxane, Strides Pharma, Teva, Teva Pharms, Watson Labs, Yiling, Alembic, Amneal, Padagis Israel, Zydus Lifesciences, Bausch, Fera Pharms Llc, Amneal Pharms, Anda Repository, Chartwell Rx, Cipla, Cosette, Fougera Pharms Inc, Glenmark Pharms Sa, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, Taro, Torrent, Xiromed, Actavis Mid Atlantic, Aurobindo Pharma, Hetero Labs Ltd Iii, Hikma, MSN, Novitium Pharma, Rubicon, Vistapharm, Lnhc, Apotex Inc, Carlsbad, Hetero Labs Ltd V, Square Pharms, Sun Pharm Inds Ltd, Zydus Pharms, Abbvie, Eurohlth Intl Sarl, Apothecon, Chartwell Injectable, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hainan Poly, Hospira, Mylan Labs Ltd, Teva Parenteral, and Glaxosmithkline, and is included in ninety-seven NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Acyclovir has forty-six patent family members in twenty-nine countries.

There are fifty-six drug master file entries for acyclovir. Sixty-eight suppliers are listed for this compound. There are three tentative approvals for this compound.

Drug Prices for acyclovir

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Drug Sales Revenue Trends for acyclovir

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Recent Clinical Trials for acyclovir

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Rehab WeridaN/A
University Hospital, ToulousePhase 1
Ho Chi Minh City Hospital of Dermato-VenereologyN/A

See all acyclovir clinical trials

Generic filers with tentative approvals for ACYCLOVIR
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial200MGCAPSULE;ORAL
⤷  Try a Trial⤷  Try a Trial800MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial400MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for acyclovir

US Patents and Regulatory Information for acyclovir

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zydus Pharms ACYCLOVIR acyclovir TABLET;ORAL 204314-002 Aug 19, 2014 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Anda Repository ACYCLOVIR acyclovir OINTMENT;TOPICAL 206437-001 Jul 31, 2017 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Square Pharms ACYCLOVIR acyclovir TABLET;ORAL 209366-002 Oct 7, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bausch ZOVIRAX acyclovir CREAM;TOPICAL 021478-001 Dec 30, 2002 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms ACYCLOVIR acyclovir TABLET;ORAL 204314-001 Aug 19, 2014 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for acyclovir

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan ZOVIRAX acyclovir CAPSULE;ORAL 018828-001 Jan 25, 1985 ⤷  Try a Trial ⤷  Try a Trial
Bausch ZOVIRAX acyclovir CREAM;TOPICAL 021478-001 Dec 30, 2002 ⤷  Try a Trial ⤷  Try a Trial
Mylan ZOVIRAX acyclovir TABLET;ORAL 020089-002 Apr 30, 1991 ⤷  Try a Trial ⤷  Try a Trial
Mylan ZOVIRAX acyclovir TABLET;ORAL 020089-001 Apr 30, 1991 ⤷  Try a Trial ⤷  Try a Trial
Bausch ZOVIRAX acyclovir OINTMENT;TOPICAL 018604-001 Mar 29, 1982 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for acyclovir

Country Patent Number Title Estimated Expiration
Germany 602007002996 ⤷  Try a Trial
Russian Federation 2420267 БИОАДГЕЗИВНЫЙ НОСИТЕЛЬ С ЗАМЕДЛЕННЫМ ВЫСВОБОЖДЕНИЕМ ДЛЯ СЛИЗИСТЫХ ОБОЛОЧЕК, ПРЕДНАЗНАЧЕННЫЙ ДЛЯ ДОСТАВКИ АКТИВНЫХ КОМПОНЕНТОВ (BIOADHESIVE CARRIER WITH DELAYED RELEASE FOR MUCOUS MEMBRANES, INTENDED FOR DELIVERY OF ACTIVE COMPONENTS) ⤷  Try a Trial
Poland 1998750 ⤷  Try a Trial
European Patent Office 2509586 COMPRIMÉS BUCCAUX MUCOADHÉSIFS POUR LE TRAITEMENT DE L'HERPÈS OROFACIAL (MUCOADHESIVE BUCCAL TABLETS FOR THE TREATMENT OF OROFACIAL HERPES) ⤷  Try a Trial
Brazil PI0709057 veìculo mucoso bioadesivo de lenta liberação, método para preparar um veìculo mucoso bioadesivo de lenta liberação, e, uso do véiculo mucoso bioadesivo de lenta liberação ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for acyclovir

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0809498 SPC/GB10/012 United Kingdom ⤷  Try a Trial PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
0809498 10C0038 France ⤷  Try a Trial PRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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